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Shoulder InjuriesNCT05451550

The Effects of General Anesthesia and Combined Anesthesia in Controlled Hypotension During Arthroscopic Shoulder Surgery

A study testing Brachial plexus block, General anesthesia and Suprascapular nerve block in people with Shoulder Injuries and Shoulder Osteoarthritis, run by General Hospital of Ningxia Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Controlled hypotension is one of the important techniques used for facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Shoulder Injuries, Shoulder Osteoarthritis
What is being tested?
Brachial plexus block, General anesthesia and Suprascapular nerve block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
17 Jul 2022to 29 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) planned elective arthroscopic shoulder surgery, need controlled hypotension under general anesthesia; (2) aged 60-75 years; (3) ASA grade II or III; and (4) estimated operative time < 120 min.

Who cannot join

  • (1) preoperative blood pressure systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg or pulse pressure ≥ 60 mmHg; (2) comorbidities of severe cardiovascular disease, including cardiac function grade III or IV, severe aortic stenosis, aortic valve insufficiency, severe coronary heart disease, bradycardia, and atrioventricular block above degree I; (3) history of cerebral infarction, Alzheimer's disease, or cerebrovascular incident; (4) liver and/or kidney dysfunction; (5) severe anemia, shock, hypovolemia, or respiratory dysfunction; (6) previous history of phlebitis or thrombosis, closed-angle glaucoma; and (7) BMI > 25 or < 18. Patients with intraoperative blood loss > 1500 mL or operation time > 4 h would be further excluded from the analysis.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Anesthesiology, General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

Other trials in China

About this study

Official title: Comparison of Effects and Safety in Providing Controlled Hypotension During Arthroscopic Shoulder Surgery Between General Anesthesia and General Anesthesia Combined With Nerve Block

Controlled hypotension is one of the important techniques used for facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. To test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia. Patients undergoing arthroscopic shoulder surgery were enrolled and divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. The dosage of vasoactive drugs and anesthetics, parameters of perioperative bleeding, hemodynamic parameters, systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups.

Read the detailed description

Controlled hypotension is one of the important techniques used for minimizing bleeding and facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Although surgical field visualization is important in arthroscopic shoulder surgery, the complications associated with controlled hypotension for surgery should be considered. The implementation of controlled hypotension requires a large amount of antihypertensive agents or anesthetics, it may cause instability of the circulatory system, organ hypoperfusion, or subsequent ischemic injury. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. However, few data are currently available in the literature evaluating brachial plexus or its branches block and controlled hypotension during arthroscopic shoulder surgery. To obtain more information on this topic, the investigators conducted this prospective randomized study to test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia.

Methods:

The inclusion criteria are (1) planned elective arthroscopic shoulder surgery, need controlled hypotension under general anesthesia; (2) aged 60-75 years; (3) ASA grade II or III; and (4) estimated operative time < 120 min. The exclusion criteria were (1) preoperative blood pressure systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg or pulse pressure ≥ 60 mmHg; (2) comorbidities of severe cardiovascular disease, including cardiac function grade III or IV, severe aortic stenosis, aortic valve insufficiency, severe coronary heart disease, bradycardia, and atrioventricular block above degree I; (3) history of cerebral infarction, Alzheimer's disease, or cerebrovascular incident; (4) liver and/or kidney dysfunction; (5) severe anemia, shock, hypovolemia, or respiratory dysfunction; (6) previous history of phlebitis or thrombosis, closed-angle glaucoma; and (7) BMI > 25 or < 18. Patients with intraoperative blood loss > 1500 mL or operation time > 4 h would be further excluded from the analysis.

The included patients were divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. For controlled hypotension during surgery, all patients were maintained with propofol/remifentanil in general anesthesia. An additional ultrasound-guided brachial plexus block or suprascapular nerve block were performed in general anesthesia combined with brachial plexus block or general anesthesia combined with suprascapular nerve block group. The dose of each agent was adjusted to maintain the mean arterial blood pressure (MAP) at 60 to 70 mm Hg and the BIS at 40 to 60. nicardipine and phenylephrine served mainly to control the target MAP, Norepinephrine and esmolol were also used as needed.

The dosage of vasoactive drugs (vasopressor-inotrope dose was calculated by adding norepinephrine equivalents of total norepinephrine, epinephrine, phenylephrine, and vasopressin dose used during surgery, using the following formula: total vasopressor-inotrope dose = [norepinephrine (µg/min) × min] + [epinephrine (µg/min) × min] + [(phenylephrine (µg/min) ×min) ÷ 10] + [vasopressin (U/h) × 8.33 × min]) and anesthetics, parameters of perioperative bleeding, hemodynamic parameters(blood pressure, heart rate, pulse oximetry), systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups. The incidence of postoperative complications (within 7 days, such as Organ dysfunction) were also recorded.

Statistical analysis and get conclusions.

Being tested
Brachial plexus block, General anesthesia, Suprascapular nerve block
Medical subject headings
Shoulder Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brachial plexus blockProcedure or surgery

    Also called General anesthesia combined with brachial plexus block group

    An additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group

  • General anesthesiaProcedure or surgery

    General anesthesia were performed according to clinical routine: induction drugs: propofol, sufentanil, rocuronium, maintenance drugs: propofol, sevoflurane and remifentanil, Laryngeal mask ventilation.

  • Suprascapular nerve blockProcedure or surgery

    Also called General anesthesia combined with suprascapular nerve block group

    An additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group

Study groups in NCT05451550
Study groupRoleWhat they receive
General anesthesia groupExperimentalPatients were maintained with propofol/remifentanil in general anesthesia
Receives: Procedure: General anesthesia
General anesthesia combined with brachial plexus block groupExperimentalAn additional ultrasound-guided brachial plexus block were performed
Receives: Procedure: Brachial plexus block; Procedure: General anesthesia
general anesthesia combined with suprascapular nerve block groupExperimentalAn additional ultrasound-guided suprascapular nerve block were performed
Receives: Procedure: General anesthesia; Procedure: Suprascapular nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The dosage of total vasopressor-inotrope dose between groups

    The dosage of total vasopressor-inotrope dose (Calculate by formula) between the groups

    Measured: 1 day

Secondary outcomes (3)
  1. The dosage of anesthetics between groups

    The dosage of propofol(milligram) and sevoflurane(milliliter) between groups

    Measured: 1 day

  2. Blood pressure between the groups

    Blood pressure(millimeter of mercury) between the groups

    Measured: 1 day

  3. The incidence of postoperative complications

    The incidence of postoperative complications (within 7 days, such as Organ dysfunction) between groups

    Measured: 3 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2022
  2. Study start17 Jul 2022 (estimated)
  3. Primary completion29 Sep 2024 (estimated)
  4. Study completion29 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05451550
Sponsor's protocol ID
Gang202207
Status last verified
Jun 2022
First submitted
20 Jun 2022
Last updated
19 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Brachial plexus block, General anesthesia and Suprascapular nerve block in people with Shoulder Injuries and Shoulder Osteoarthritis, run by General Hospital of Ningxia Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gang Ma, doctor (13709519220 ext. +86, magang2671@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The dosage of total vasopressor-inotrope dose between groups (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.

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